Recall Z-0565-2013— Del Mar Reynolds Medical, Ltd.

Name: FDA recall Z-0565-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Class II · Terminated

Class II FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2012-11-02, terminated 2013-07-11. It names one FDA 510(k) clearance: K003251. Product: BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.. Reason: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available..

Recalling firm: Del Mar Reynolds Medical, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Terminated: 2013-07-11
Firm location: Hertford, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K003251 — BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690Blease Medical Equipment , Ltd.·cleared 2001-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

Reason for recall

The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

Data sourced from openFDA. This site is unofficial and independent of the FDA.